N/A
Completed N=30
Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
Prostatectomy
Source: ClinicalTrials.gov NCT03624465 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Number of Tools Required to Retract the Prostate During Procedure — 0 Additional Tools to Mobilize Liver
Summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Tools Required to Retract the Prostate During Procedure |
— | — |
| PRIMARY Incidence of Device Related Adverse Events (Safety) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject is at least 18 years of age
- Subject is scheduled to undergo elective prostatectomy surgery
Exclusion Criteria
- Significant comorbidities
- Subjects with pacemakers, defibrillators, or other electromedical implants
- Subjects with ferromagnetic implants
- Clinical history of impaired coagulation
- Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
- Subject is not likely to comply with the follow-up evaluation schedule
- Subject is participating in another clinical trial
Data sourced from ClinicalTrials.gov (NCT03624465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.